In:
Respirology, Wiley, Vol. 27, No. 12 ( 2022-12), p. 1034-1044
Abstract:
Chronic mucus hypersecretion (CMH) is a clinical phenotype of COPD. This exploratory post hoc analysis assessed relationship between CMH status and treatment response in IMPACT. Methods Patients were randomized to once‐daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 μg, FF/VI 100/25 μg or UMEC/VI 62.5/25 μg and designated CMH+ if they scored 1/2 in St George's Respiratory Questionnaire (SGRQ) questions 1 and 2. Endpoints assessed by baseline CMH status included on‐treatment exacerbation rates, change from baseline in trough forced expiratory volume in 1 second, SGRQ total score, COPD Assessment Test (CAT) score, proportion of SGRQ and CAT responders at Week 52 and safety. Results Of 10,355 patients in the intent‐to‐treat population, 10,250 reported baseline SGRQ data (CMH+: 62% [ n = 6383]). FF/UMEC/VI significantly ( p 〈 0.001) reduced on‐treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in CMH+ (rate ratio: 0.87 and 0.72) and CMH− patients (0.82 and 0.80). FF/UMEC/VI significantly ( p 〈 0.05) reduced on‐treatment severe exacerbation rates versus UMEC/VI in CMH+ (0.62) and CMH− (0.74) subgroups. Similar improvements in health status and lung function with FF/UMEC/VI were observed, regardless of CMH status. In CMH+ patients, FF/VI significantly ( p 〈 0.001) reduced on‐treatment moderate/severe and severe exacerbation rates versus UMEC/VI (0.83 and 0.70). Conclusion FF/UMEC/VI had a favourable benefit: risk profile versus dual therapies irrespective of CMH status. The presence of CMH did not influence treatment response or exacerbations, lung function and/or health status. However, CMH did generate differences when dual therapies were compared and the impact of CMH should be considered in future trial design.
Type of Medium:
Online Resource
ISSN:
1323-7799
,
1440-1843
Language:
English
Publisher:
Wiley
Publication Date:
2022
detail.hit.zdb_id:
2010720-1
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